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Researchers use machine learning to engineer 'bespoke enzymes' for gene editing

Science Daily: Pharmacology News

Genome editing has advanced at a rapid pace with promising results for treating genetic conditions -- but there is always room for improvement. A new paper showcases the power of scalable protein engineering combined with machine learning to boost progress in the field of gene and cell therapy. In their study, authors developed a machine learning algorithm -- known as PAMmla -- that can predict the properties of about 64 million genome editing enzymes.

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Microplastics Could Be Contributing To Clogged Arteries

Drugs.com

WEDNESDAY, April 23, 2025 Microplastics could be contributing to clogged arteries, increasing peoples risk of heart attack or stroke, a new study says.Fatty plaques in neck arteries can contain more than 50 times as much microplastics as are fou.

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Identification of a phenyl ester covalent inhibitor of caseinolytic protease and analysis of the ClpP1P2 inhibition in mycobacteria

Covalent Modifiers

Genhui Xiao, Yumeng Cui, Liangliang Zhou, Chuya Niu, Bing Wang, Jinglan Wang, Shaoyang Zhou, Miaomiao Pan, Chi Kin Chan, Yan Xia, Lan Xu, Yu Lu, Shawn Chen mLife , 2025 DOI: [link] The caseinolytic protease complex ClpP1P2 is crucial for protein homeostasis in mycobacteria and stress response and virulence of the pathogens. Its role as a potential drug target for combating tuberculosis (TB) has just begun to be substantiated in drug discovery research.

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Novo says it’s submitted obesity pill for FDA approval

BioPharma Drive: Drug Pricing

A spokesperson confirmed the Danish drugmaker has asked U.S. regulators to clear an oral version of its weight loss drug Wegovy two years after reporting initial Phase 3 results.

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Bridging Innovation & Patient Care: The Growing Role of AI

Speaker: Simran Kaur, Co-founder & CEO at Tattva.Health

AI is transforming clinical trials—accelerating drug discovery, optimizing patient recruitment, and improving data analysis. But its impact goes far beyond research. As AI-driven innovation reshapes the clinical trial process, it’s also influencing broader healthcare trends, from personalized medicine to patient outcomes. Join this new webinar featuring Simran Kaur for an insightful discussion on what all of this means for the future of healthcare!

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CDC Cancels Measles Help for Texas Schools Amid Staff Layoffs

Drugs.com

MONDAY, April 21, 2025 The U.S. Centers for Disease Control and Prevention (CDC) has canceled its plans to help Texas schools stop the rapid spread of measles. The decision came after some CDC staff involved in this years outbreak response were t.

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High-fat, high-sugar diets impact cognitive function

Science Daily: Pharmacology News

New research links fatty, sugary diets to impaired brain function. The findings build on a growing body of evidence showing the negative impact of high-fat, high-sugar (HFHS) diets on cognitive ability, adding to their well-known physical effects.

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Reports Document FDA Review Delays: What Drugmakers Should Know Now

FDA Law Blog: Drug Discovery

By John W.M. Claud & Michelle L. Butler Recent reductions in force (RIFs) and leadership changes at FDA are already affecting key agency functionsand as the administration plans a broader reorganization, the impact will likely grow. One area drawing increasing attention is how these changes will affect the drug development and review process. As reported by the Wall Street Journal last week , reviews of both innovative and follow-on drugs have been caught in a traffic jam, largely due to a

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Roche, answering tariff threat, pledges $50B to US drug production

BioPharma Drive: Drug Pricing

The big pharma joined several of its peers in committing to invest billions of dollars in new and expanded manufacturing facilities in the U.S.

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Supreme Court Case Targets Free Preventive Care Provided By The Affordable Care Act

Drugs.com

MONDAY, April 21, 2025 -- Colonoscopy for younger adults. Chest CT scans for lung cancer. Statin meds to lower cholesterol. Screening for drug addiction.More than 150 million Americans might lose no-cost access to these and other preventive care.

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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

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Partnering with Eli Lilly to Empower the Biomedical Workforce

keypoint

Keystone Symposia was founded on the idea of bringing academic and industry scientists together to accelerate translational advances that cannot be achieved without their combined expertise and resources. As such, we have a long history of partnership with industry leaders with the shared goal of integrating basic science discovery and innovation into drug development efforts to yield novel and improved targeted treatment strategies.

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Childhood exposure to bacterial toxin may be triggering colorectal cancer epidemic among the young

Science Daily: Pharmacology News

An international team has identified a potential microbial culprit behind the alarming rise in early-onset colorectal cancer: a bacterial toxin called colibactin. Scientists report that exposure to colibactin in early childhood imprints a distinct genetic signature on the DNA of colon cells -- one that may increase the risk of developing colorectal cancer before the age of 50.

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Crinecerfont

New Drug Approvals

Crinecerfont CAS 752253-39-7 SSR125543 SSR 125543 SSR-125543, WHO 10958 , UNII-MFT24BX55I , 06-RORI,NBI-74788 (S)-4-(2-chloro-4-methoxy-5-methylphenyl)-N-(2-cyclopropyl-1-(3-fluoro-4-methylphenyl)ethyl)-5-methyl-N-(prop-2-yn-1-yl)thiazol-2-amine 2-Thiazolamine, 4-(2-chloro-4-methoxy-5-methylphenyl)-N-((1S)-2-cyclopropyl-1-(3-fluoro-4-methylphenyl)ethyl)-5-methyl-N-2-propynyl- 2-Thiazolamine, 4-(2-chloro-4-methoxy-5-methylphenyl)-N-[(1S)-2-cyclopropyl-1-(3-fluoro-4-methylphenyl)ethyl]-5-methyl-N-

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FDA cuts outlined in draft HHS budget

BioPharma Drive: Drug Pricing

The leaked budget draft, if approved by Congress, would reduce the FDA’s budget authority, indicating more disruption could be in store for an agency already shaken by large-scale layoffs.

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How Machine Learning Drives Clinical Trial Efficiency

Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.

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Case Study: How Altasciences Overcame Pharmacological Challenges in a GLP-1 IND-Enabling Study

Alta Sciences

Case Study: How Altasciences Overcame Pharmacological Challenges in a GLP-1 IND-Enabling Study pmjackson Thu, 04/24/2025 - 21:43 For emerging therapies with pronounced pharmacological effects, thoughtful study design is critical to ensuring reliable and interpretable data. In preclinical studies , the same effects that make GLP-1 receptor agonists (RA) effective treatments for appetite suppression and weight loss, can often become obstaclescomplicating the evaluation of toxicological outcomes du

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The eukaryotic cell emerged as an evolutionary algorithmic phase transition

Science Daily: Pharmacology News

An international collaboration has published groundbreaking research, shedding light on the most significant increase in complexity in the history of life's evolution on Earth: the origin of the eukaryotic cell.

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Landiolol

New Drug Approvals

Landiolol 133242-30-5 ONO-1101 Ono 1101 WHO 7516 FDA APPROVED 11/22/2024, Rapiblyk , To treat supraventricular tachycardia C25H39N3O8 509.6 g/mol [(4 S )-2,2-dimethyl-1,3-dioxolan-4-yl]methyl 3-[4-[(2 S )-2-hydroxy-3-[2-(morpholine-4-carbonylamino)ethylamino]propoxy]phenyl]propanoate [(4S)-2,2-dimethyl-1,3-dioxolan-4-yl]methyl 3-[4-[(2S)-2-hydroxy-3-[2-(morpholine-4-carbonylamino)ethylamino]propoxy]phenyl]propanoate UNII-62NWQ924LH (S-(R*,R*))-(2,2-Dimethyl-1,3-dioxolan-4-yl)methyl 4-(2-hydroxy-

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Merck takes $200M tariff hit, trimming its gross profits

BioPharma Drive: Drug Pricing

The drugmaker absorbed additional tariff-related costs in the first quarter, but has taken steps to lower the financial impact it’ll have for the rest of the year and beyond.

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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.

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First Weight-Loss Pill From Lilly, Orforglipron, Shows Promising Results

Drugs.com

FRIDAY, April 18, 2025 — A new pill designed to help with weight loss and blood sugar control is showing promise in early studies. Eli Lilly said its experimental drug, orforglipron, helped people with type 2 diabetes lower their blood sugar.

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Navigating FDA Layoffs: How Policy Layoffs May Impact Generic Drug Development

thought leadership

Explore how FDA layoffs affecting the OGDP may impact generic development & how experienced regulatory consultants can help you stay on track.

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More Americans are using psilocybin -- especially those with mental health conditions, study shows

Science Daily: Pharmacology News

Use of psilocybin, the hallucinogenic chemical found in what is known as 'magic mushrooms,' has increased significantly nationwide since 2019, according to a new study.

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Bocodepsin

New Drug Approvals

Bocodepsin, OKI-179 CAS 1834513-65-3 1834513-67-5 (besylate) K5D067O1SW S-((3E)-4-((6S,9S)-12,12-DIMETHYL-4,8,11,14-TETRAOXO-9-(PROPAN-2-YL)-7-OXA -3,10,13-TRIAZA-1(2,4)-(1,3)THIAZOLACYCLOTETRADECAPHAN-6-YL)BUT-3-EN-1-YL) (2S)-2-AMINO-3-METHYLBUTANETHIOATE S-(4-((7S,10S)-4,4-DIMETHYL-2,5,8,12-TETRAOXO-7-(PROPAN-2-YL)-9-OXA-16-THIA- 3,6,13,18-TETRAAZABICYCLO(13.2.1)OCTADECA-15(18),17-DIEN-10-YL)BUT-3-EN-1-YL) (2S)-2-AMINO-3-METHYLBUTANETHIOATE Molecular Weight 581.75 Formula C 26 H 39 N 5 O 6 S 2

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Clinical Data Like You´ve Never Seen It Before: Why Spotfire Is the Leading Tool for Clinical Analytics

Clinical development organizations face a wide array of challenges when it comes to data, many of which can impact the operational effectiveness of their clinical trials. In this whitepaper, experts from Revvity Signals explore how solutions like TIBCO® Spotfire® enable better, more streamlined studies. The whitepaper also features a success story from Ambrx, a leading biopharmaceutical company, detailing how it has leveraged Spotfire to tackle data quality and collaboration challenges in clinic

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Etiome, a new Flagship startup, looks to catch disease before it strikes

BioPharma Drive: Drug Pricing

The biotech is using AI and a trove of health data to better understand why certain conditions progress and intervene beforehand with a targeted medication.

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Cutting-Edge Cancer Treatment, CAR T-Cell Therapy, Isn't Known By Most Americans

Drugs.com

MONDAY, April 21, 2025 -- Chris Vogelsang has had a long and terrible fight with cancer. Fourteen years ago, the 70-year-old man was first diagnosed with an aggressive form of lymphoma. His cancer has since returned twice, fighting against several.

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Closing Deals Faster: The Future of Sales with AI & Personalization

Perficient: Drug Development

Need faster closing deals ? How the digital world helps accelerate the process. The secret isnt just technologyits how you use it. Glenn Kline, General Manager of Perficients Microsoft Business Unit, unveils powerful strategies to transform customer experiences and turn opportunities into real results in this exclusive interview. From hyper-personalization to generative AI, discover how Salesforce solutions redefine how businesses drive sales, leading to more effective closing deals.

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High-tech sticker can identify real human emotions

Science Daily: Pharmacology News

Saying one thing while feeling another is part of being human, but bottling up emotions can have serious psychological consequences like anxiety or panic attacks. To help health care providers tell the difference, a team has created a stretchable, rechargeable sticker that can detect real emotions -- by measuring things like skin temperature and heart rate -- even when users put on a brave face.

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IRA Fallout: What 2025 Medicare Shifts Mean for Patient Access and Market Strategy

Drug Channels

Todays guest post comes from Scott Hughes, Vice President of Strategy of CareMetx. In this latest analysis from CareMetx, Scott explores how the Inflation Reduction Act (IRA) is reshaping Medicare patients access to critical medications across three high-impact therapeutic areas: immunology, oncology, and endocrinology. Drawing on fresh 2025 plan data, he highlights the emerging barriers faced by patients, the shifting demands on providers, and the strategic implications for drug manufacturers.

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Former Neumora CEO to lead Galapagos spinout

BioPharma Drive: Drug Pricing

Henry Gosebruch is now chief executive of the spinout, which has roughly $2.5 billion and plans to use dealmaking to build a research pipeline targeting cancer, viruses and the immune system.

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Federal Prosecutor Questions Medical Journals Over Alleged Bias

Drugs.com

WEDNESDAY, April 23, 2025 At least three medical journals have received letters from a top federal prosecutor questioning whether they mislead readers or allow political bias to influence what they decide to publish.The letters were signed by E.

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The Future of Work: Letting AI Handle Responsibility While Humans Maintain Accountability

Perficient: Drug Development

The Future of Work: Letting AI Handle Responsibility While Humans Maintain Accountability In today’s rapidly evolving technological landscape, we’re witnessing a fundamental shift in how we conceptualize the division of labor between artificial intelligence and human workers. Rather than viewing AI as simply another tool in our arsenal, forward-thinking organizations are reconsidering the entire paradigm of responsibility and accountability in the workplace.

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